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Guidance Documents/Guidance-Document/Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing

Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

June 2, 2026

June 2, 2026

Center for Biologics Evaluation and Research

4ed1473e-e7aa-43b9-89a0-6a6910525833

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